Evaluation of the Efficacy of Surfaktant in Preterm Infants by Lung Ultrasound

Evaluation of the Efficacy of Different Surfactant Preparations in Preterm Infants by Lung Ultrasound

To compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. Poractant alfa decreases lung ultrasound scores as efficient as beractant treatment

Study Overview

• Status: Unknown
• Conditions: Lung Ultrasound Scores
• Intervention / Treatment: Device: group 1 Poractant alfa; Device: group 2 beractant

Detailed Description

Outcomes:

Improvement of Lung usg scores after surfactanct and the difference between groups at different time points (2nd and 6hr).

Secondary outcome:

The correlation between lung usg scores and clinical scores (silverman scores), FiO2 and PCO2 levels, failure of weaning to noninvasive ventilation after surfactant Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davut Bozkaya, MD; Phone Number: +905053197531; Email: drbozkaya@gmail.com
• Study Contact Backup: Name: Evrim Alyamaç Dizdar, MD; Phone Number: +905063668840; Email: drevrimdizdar@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Recruiting
    • Zekai Tahir Burak Matarnity Teaching
    • Contact: Davut Bozkaya, MD; Phone Number: +905053197531; Email: drbozkaya@gmail.com
    • Contact: Şebnem Özyer, MD; Phone Number: +903123065272; Email: sebnemsenozyer@yahoo.com,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 6 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.

Exclusion Criteria:

• major congenital anomalies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1 Poractant alfa; Poractant alfa generic name: curosurf 120 and 240 mg flk dosage: 200 mg/ kg intratracheal application frequency and duration: in the first two hours	Device: group 1 Poractant alfa; Comparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
Active Comparator: group 2 beractant; beractant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours	Device: group 2 beractant; lComparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung usg scores	Evaluation of Lung Usg Scores in infants treated with surfactant in the first six hours (Brat lung usg scores). Each item scored 0-3. (0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.) - Higher values represent a worse outcome	first days

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
• Investigators: Study Director: Evrim Alyamaç Dizdar, MD, zekai tahir burak matarnity teaching hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Anticipated): January 30, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Lung; RDS; Surfaktant
• Additional Relevant MeSH Terms: Respiratory System Agents; Pulmonary Surfactants; Poractant alfa; Beractant
• Other Study ID Numbers: 22032018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No